BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 739767 · Received July 21, 2006

    Report

    Report Number
    3002719998-2006-00009
    Event Type
    Other
    Date Received
    July 21, 2006
    Date of Event
    January 31, 2006
    Report Date
    July 20, 2006
    Manufacturer
    *
    Product Code
    HWF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    TISSUE NOT RETURNED FOR ANALYSIS. INVESTIGATION/REVIEW OF INTERNAL RECORDS; DONOR, SEROLOGICAL RESULTS, MEDICAL RELEASE, MANUFACTURING, QUALITY ASSURANCE/QUALITY CONTROL REVIEWS, AND PROCESSING CULTURES. RESULTS NO DEVIATIONS NOTED DURING INTERNAL RECORD REVIEW. STERILITY (14-DAY), AND DESTRUCTIVE CULTURES NEGATIVE FOR AEROBIC, AND ANAEROBIC GROWTH. DONOR SEROLOGY TESTS NEGATIVE. GRAFT PASSED ALL RELEASE CRITERIA PRIOR TO DISTRIBUTION. CONCLUSION: BIOCLEANSE , THE PROCESSING METHOD UTILIZED FOR IMPLANTED GRAFT, IS A VALIDATED PROCESS FOR STERILIZING ALLOGRAFT TISSUE. THE ONSET OF INFECTION WEEKS AFTER INITIAL PROCEDURE IS MOST LIKELY ASSOCIATED WITH CONCURRENT IMPLANTATION OF HARDWARE. INFECTION FROM A SOURCE OTHER THAN ALLOGRAFT IMPLANT TISSUE IS LIKELY.

    Description of Event or Problem · 1

    PATIENT HAS INFECTED KNEE AND, SURGEON STATES GRAFT HAS DISINTEGRATED. SURGERY PERFORMED IN 2005 UTILIZING AN ALLOGRAFT TENDON MANUFACTURED BY RTI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * * HWF * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other